ELITex Bicolor Mono

Intended use

Infectious mononucleosis is a disease caused by Epstein-Barr virus, relatively frequent, usually harmless and often causing a high asthenia. From the earliest days of disease, heterophile antibodies of infectious mononucleosis are present in the serum in sufficient quantity to allow diagnosis. They disappear gradually but can persist up to 3 months.

These heterophile antibodies can agglutinate sheep, horse, beef and rabbit red blood cells.
ELITex Bicolor Mono is a rapid test for the detection of infectious mononucleosis heterophile antibodieswhich appear at the beginning of the disease.

Principle

ELITex Bicolor Mono is a direct agglutination slide test. The TEST LATEX consists of latex particles sensitized by erythrocytes stroma specially treated, making unnecessary the adsorption of other heterophile antibodies and ensuring the reaction specificity.

The presence of heterophile antibodies in sera is revealed by a red agglutination on a more or less intense blue background, visible to the naked eye. Otherwise, no agglutination is observed and the suspension remains homogeneous with a uniform purple color.

Handling is simple and fast. It is performed on pure serum and the results are obtained in 2 minutes.

Simple protocol

Easy-to-read and easy-to-interpret results

The kit contains an internal quality control which allows observing a positive and a negative reaction as described below:

Reagents and material

• TEST LATEX:
  Dispenser vial containing 1.5 mL of sensitized latex
• CONTROL +:
  Dispenser vial containing 0.5 mL of positive control
• CONTROL -:
  Dispenser vial containing 0.5 mL of negative control
• TEST CARD:
  5 disposable reaction cards

Stability and storage

• All reagents are ready-to-use.
• Reagents stored at 2-8°C, in their original state, are stable up to the expiry date indicated on the box.
• They must not be frozen.
• The shelf life of the product, from its manufacture, is 24 months.

Performance

• A study made on 308 human negative sera and 64 human positive sera has demonstrated that the test ELITex Bicolor Mono has a sensitivity of 98.4% and a specificity of 99.7%.

Material required but not provided

• Automatic pipette(s) with a pipetting volume adapted to the volume that will be measured
• Contaminated waste container